Novel device for assessing endotracheal tube placement

ABSTRACT

A novel connection device, and method for its use, for connecting a volume displacement detection device and a gas composition detection device in line with an intubation tube is disclosed. The connection device allows a user to combine two systems commonly employed by medical personnel to assess the location of an intubation tube placed into a patient. The two systems have alternate means of assessing the location of an intubation tube in a patient and therefore, when combined into a single unit via the connection device, improve the accuracy of placing a tube in a desired location while reducing or eliminating complications associated with misplacement. A kit comprising components that may be assembled to provide a device for assessing the proper placement of an intubation tube in a patient is also disclosed. The kit may be used in any environment, but is particularly well suited for emergency, pre-hospital settings requiring intubation where quick assembly of the components is essential.

FIELD OF THE INVENTION

[0001] The present invention is directed to a device used to connect twoor more intubation placement detectors in line with an endotracheal tube(ETT) to provide rapid, alternative methods of assessing whether an ETThas been properly placed in the trachea of a patient.

BACKGROUND OF THE INVENTION

[0002] Ventilation of the lungs is essential to life. Patients in needof medical attention often require assistance with breathing as a resultof injury, trauma, or airway obstruction. In an apneic patient, thelungs must be artificially ventilated to ensure proper oxygenation andexchange of gasses within the body. Endotracheal intubation is thetechnique of placing an endotracheal tube (ETT) into the trachea of apatient, for the purposes of establishing an airway. It is estimatedthat over 18 million intubations are preformed each year in the US, themajority in the operating room. Because of the close proximity of theesophagous to the trachea, an intubationist may accidentally place theETT into an esophagous. If the error is detected immediately, no harmresults. However, if the incorrect placement is not recognized and theETT repositioned, within a few minutes irreversible brain damage and/ordeath may result, due to the lack of oxygen. In an ideal setting, anintubationist places an ETT in one hand and visualizes the glotticopening of the airway by introducing a larygoscope into the mouth. TheETT is then carefully passed into the trachea and attached to a sourceof oxygen. However, even under such controlled conditions inadvertantesophageal intubations have been reported. (White, S. J. and C. M.Slovis, Acad Emerg Med 1997:4:89-91) This problem is magnified inout-of-hospital intubations performed, or in the hospital outside of theOR and ER wards and intensive care units under less than idealconditions such as, for example, at the scene of an accident, or withinan ambulance in route to a hospital. Under such stressful and oftenchaotic conditions, misplacement of an ETT in a patient is not uncommon.

[0003] In an effort eliminate the danger inherent in unrecognizedesophageal intubation, numerous clinical methods and devices have beendeveloped to rapidly assess tube placement. Qualitative methods includedirect visualization, observation of chest movement with bag inflation,auscultation of breathing sounds, absence of epigastric sound withventilation, presence of exhaled tidal volume, reservoir bag compliance,endotracheal cuff maneuvers, absence of air escape, tube condensationwith exhalation, absence of gastric contents within the tube and others(O'Connor, R. E. R. A. Swor Prehospital Emergency Care July-Sept. 1999).Each of these methods have utility in a limited range of clinicalconditions.

[0004] Quantitative methods have also been employed to better assessendotracheal tube placement. The most common quantitative means todocument correct placement of an endotracheal tube (ETT) is to sensecarbon dioxide during the exhalation phase of ventilation. The successof this method is based on the difference between the CO₂ concentrationin exhaled air (5%) and the CO₂ concentration in esophagael gas(0.2%-0.3%). Documentation of carbon dioxide in the exhaled breath hasbecome the accepted standard for verifying the correct placement of anendotracheal tube, unless the location can be directly visualized, forinstance, with a fiberoptic bronchoscope. Numerous devices have beendeveloped for assessing proper endotracheal tube placement throughdetection of CO₂, the utility of each varying with the particularclinical condition.

[0005] The most common CO₂ detection device employed in hospitals is thecapnometer. This device is used to monitor the concentration of exhaledcarbon dioxide in order to assess the physiologic status of a patient.The device comprises an infrared sensor that continuously monitors anddisplays CO₂ concentration and generates a waveform (capnogram) that iscorrelated with a patient's respiratory cycle to quantitatively assessthe adequacy of ventilation.

[0006] However, these devices are less reliable when there is apulmonary embolis or a patient is in cardiac arrest. (Garnett, A R etal., JAMA 1987; 257: 512-515) Further, traditional capnometers areexpensive, sophisticated, and fragile instruments requiring carefulcalibration and a source of power, making their use in out-of hospitalprocedures impractical. Thus, in emergency-type settings, a capnometermay be inadequate. In those situations, alternative devices areemployed. The most reliable method for verifying proper tube placementin out-of hospital applications is through use of an end-tidal carbondioxide detection device (Ornato, J P Ann. Emerg Med 1992; 21:518-523)The EasyCap End-Tidal CO₂ Detector (Nellcor-Mallincrodt-Tyco) is aninexpensive, disposable device that quickly attaches to an ETT to senseexhaled CO₂. With each breath, CO₂ exhaled passes over an indicator inthe device that has been treated with a chemical that turns color inresponse to high CO₂ concentration. Thus, a change in color of theindicator is indicative of proper placement of the ETT in the tracheabecause of the substantially higher concentration of CO₂ in exhaled airas previously discussed. Tube placement anywhere but the trachea willnot yield a color change. However, even if the ETT is properly placed,the EasyCap, like the more expensive capnometer, is inadequate in thoseinstances where a patient lacks a pulse or has very poor pulmonaryperfusion because without CO₂ exchange from pulmonary arterial blood toalveoli, insufficient CO2 will be exhaled to produce a color change.

[0007] To overcome these problems, other devices that do not directlydepend on the detection of CO₂ have been developed. These esophagealdetector devices (EDD), work on principles of gas volume displacementand depend on the structural difference between the trachea and theesophagus. In one embodiment, a catheter-tip syringe is connected to anETT via a length of rubber tubing (Wee, M Y K Anaesthesia 1988 43:27-29)In use, negative pressure is created within the ETT through aspirationof the syringe chamber, i.e. withdrawal of the plunger from the syringe.If the ETT is placed in the esophagus, the walls of the esophaguscollapse upon the ETT in response to this negative pressure, which inturn restricts air-flow that can be easily detected as resistance toplunger movement. However, when the ETT is placed in the trachea thisnegative pressure is incapable of causing the more rigid trachea tocollapse, thereby allowing free exchange of air. Thus, free movement ofthe plunger is indicative of proper placement within the trachea.(O'Leary J. J. Anaesthesia and Intensive Care 1988; 16: 299-301) In analternate embodiment, a rubber bulb is attached to an ETT. (Nunn, J F.Anaesthesia 1988;43:804) In use, the bulb is compressed prior toattachment to the ETT to create a negative pressure within the ETT. Asdescribed above, if the tube is placed within the esophagus air passagebecomes restricted as the esophageal walls collapse around the ETT, butair freely flows if the ETT is properly placed in the trachea. Thus,passive re-inflation of the bulb is indicative of tracheal intubation,while the failure of the bulb to re-inflate is indicative of esophagealintubation. Each of these devices is portable, inexpensive, easilyassembled and provides faster assessment of ETT position than both thecapnometer and EasyCap described above, making them particularly wellsuited for intubations. performed outside the operating room (e.g. inthe recovery room, emergency room, intensive care unit and out in thefield). Further, these devices are useful in patients experiencingcardiac arrest because the test results do not depend upon the presenceof CO₂ in exhaled gas (Haridas, R P Update in Anaesthesia 1997;7:6(1))However, regurgitation of gastric air, distension of the esophagus withair, or an EDD that is not airtight may cause the bulb to re-inflate,giving a false impression of tracheal intubation when the tube is infact in the esophagus. (Haridas, R P Update in Anaesthesia 1997; 7:6(3))Further, although these devices are highly accurate when used in ahospital setting, studies indicate that they are only 50% accurate whenused in the field by paramedics (Pelicio, M. Acad Emerg. Med1997:4563-568)

[0008] The National Association of EMS Physicians has recognized that nosingle technique for assessing ETT tube placement currently used iscompletely reliable in all circumstances. (O'Connor, R. E. and R. A.Swor Pre-Hospital Emergency Care; July-Sept. 1999) Based on the inherentlimitations in each device, it has become apparent to the authors thatthe optimal method of detecting proper ETT placement, particularly inout-of-hospital settings would incorporate both concepts of CO₂detection and gas volume displacement to increase the accuracy of ETTplacement to near 100%.

SUMMARY OF THE INVENTION

[0009] The present invention comprises a connection device useful inconnecting a CO₂ detection device and a volume displacement device inline with an endotracheal tube (ETT). The device further comprises atleast one positive pressure response valve and at least one negativepressure response valve to allow a user to control the movement of gas.By combining two or more existing ETT placement detectors in one unit,the present device allows a user to rapidly obtain alternatequantitative measurements of ETT placement in a patient in wide varietyof clinical settings, both in and out of a hospital. The primary benefitof the present device is the ability to quickly discern with almostcomplete certainty the location of an ETT. Since incorrect placement ofan ETT is not uncommon in situations of low blood flow, particularlycardiac arrest, this device offers several advantages over existingdevice, including improved specificity, sensitivity and full operationwithout the need for an electrical hookup. The benefit to the patient inany environment is obvious.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010]FIG. 1 Depicts one embodiment of a device used to connect multipleendotracheal tube placement detection devices in line with andendotracheal tube.

[0011]FIG. 2A Depicts one embodiment of the device with a bulb-in-a-bulbvolume displacement device, a CO2 detection device and an endotrachealtube connected together as a system. As shown the volume displacementdevice has been employed to create a negative pressure in the system toretrieve a sample of gas.

[0012]FIG. 2B Depicts one embodiment of the device with a bulb-in-a-bulbvolume displacement device, a CO2 detection device and an endotrachealtube connected together as a system. As shown the volume displacementdevice has been employed to create a positive pressure in the system toforce the gas collected into a CO₂ detector for analysis.

[0013]FIG. 3A Depicts one embodiment of the device with a dual syringevolume displacement device, a CO2 detection device and an endotrachealtube connected together as a system. As shown the volume displacementdevice has been employed to create a negative pressure in the system toretrieve a sample of gas.

[0014]FIG. 3B Depicts one embodiment of the device with a dual syringevolume displacement device, a CO2 detection device and an endotrachealtube connected together as a system. As shown, the volume displacementdevice has been employed to create a positive pressure in the system toforce the gas collected into a CO₂ detector for analysis.

DESCRIPTION OF THE PREFERRED EMBODIMENT

[0015]FIG. 1 shows a novel device, generally represented at 100, used toconnect both a CO₂ detection device and a volume displacement detectorin line with an ETT. In a preferred embodiment the device comprisesfirst 101 and second 102 volume displacement detector portals, a CO₂detector portal 103 and an endotracheal tube portal 104. The portals101, 102, 103 and 104 are configured to connect with other appropriatedevices via slip fittings, friction fittings, threaded fittings, orsimilar detachable fittings. The device comprises first 110 and second112 positive pressure response valves which open when positive pressureis applied to the device 100 (see FIGS. 2B and 3B). First 111 and second113 negative response valves are also incorporated into the device 100and configured such that they open when negative pressure is applied tothe device 100. (see FIGS. 3A and 3B) Preferably, the device ismanufactured from inexpensive material such that it may be disposed offollowing use.

[0016]FIG. 2A shows one embodiment of the device with an EasyCap CO₂detector, a bulb-in-a bulb volume displacement detector, and anendotracheal tube connected. The device 100 is connected to a volumedisplacement detector 201, which preferably comprises an inner balloon202 a enclosed within an outer balloon 202 b. The volume displacementdetector 201 is connected with the device 100 such that the detectors'inner balloon 202 a communicates with the first volume displacementdevice connector 101, and the detectors' outer balloon 202 bcommunicates with the second volume displacement device connector 102. ACO₂ detector device 210 is connected to the device 100 via the CO₂detection device connector 103. As shown the CO₂ detector comprises anintake port 211 leading to a CO₂ indicator 212 which may be visualizedby a user, and an exhaust port 213. An endotracheal tube (ETT) 220 isconnected to the device 100 via the endotracheal tube connector 104.These components are assembled as a system having a system volume and asystem pressure. In use, a three step process is commenced to obtain twoindications of the proper placement of an ETT tube. First a clinicianinserts the endotracheal tube into the mouth or nose and throat of apatient. Second, a negative pressure is created in the system. This isdone by compressing the volume displacement detector 201 and thenconnecting it to the device 100. As the detector 201 attempts to regainits original shape and by increasing its volume, a partial vacuum(negative pressure) is created in the system. This negative pressureforces both first 110 and second 112 negative pressure response valvesto open. As the first valve 110 opens, atmospheric air is drawn into theCO₂ detector 210 via an exhaust port 213, over an indicator 212, out ofthe detector 210 via the intake port 213, and into the device 100 whereit passes through the open first valve 110 and into the inner balloon202 a to aid reinflation. In this instance, the CO₂ detector does notexhibit a color change because there is insufficient CO₂ in atmosphericair to activate the indicator 212. Simultaneously, the second negativepressure response valve 112 opens. In response to the negative pressuregenerated, gas moves out a patient, passes through the ETT 220, throughthe open second negative pressure response valve 112 and into the outerballoon 202 b. If the tube is misplaced into the esophagus, the negativepressure created within the ETT will cause the flexible walls of theesophagus to collapse around the end of the tube, thereby preventing airfrom flowing through the valve 112 and into the outer balloon 202 b. Ifhowever, the tube is properly placed into the trachea, the rigid, ringedwalls of the trachea will not collapse around the tube in response tothe negative pressure, and air will freely flow from the patient throughthe valve and into the outer balloon 202 b causing it to re-inflate.Rapid, passive inflation of the detector 201 is indicative of trachealintubation. However, if the tube is mistakenly placed into theesophagus, the detector may passively inflate as a result of gastricdistension or other causes as previously described, and provide a falsereading. Thus, to ensure accurate assessment of ETT placement, a secondmeasurement is employed.

[0017]FIG. 2B depicts the third step of the process which comprisescompressing the volume displacement detector 201 thereby decreasing thesystem volume and increasing the system pressure which forces gasretrieved from second step, out of the detector, through first 111 andsecond 113 positive pressure response valves, and into a CO₂ detectiondevice 210. As shown, an EasyCap End Tidal CO₂ detector(Nellcor-Mallincropt-Tyco) is employed as the CO₂ detector. However, oneskilled in the art will recognize that multiple variations on CO₂detection devices fall within the scope of this disclosure. When a usercompresses the volume detector device 201, gas from the inner balloon202 a is forced into the device 100, causing the system volume todecrease and the system pressure to increase which in turn forces afirst positive pressure response valve 111 to open, whereupon the gasescapes to the outside environment. Simultaneously, gas from the outerballoon 202 b is forced into the device 100, which in turn forces asecond positive pressure response valve 113 to open. This gas proceedsthrough the valve 113, and into the CO₂ detector 210 via the intake port211. The gas then passes over a CO₂ indicator 212 before exiting thedetector 210 via an exhaust port 213. If the ETT is properly placed inthe trachea, this gas will have a CO₂ concentration sufficient totrigger a color change in the detector that is indicative of trachealintubation. If the ETT has not been properly placed, the gas will have alow CO₂ concentration indicating it has come from the stomach or areaother than the trachea, and no color change will occur.

[0018] In another embodiment, dual syringes are substituted for thebulb-in-a-bulb design shown in FIGS. 2A and 2B. All other elementsremain the same. FIG. 3A shows the device with a preferred embodiment ofa dual syringe 301 design attached. The dual syringe comprises first 302a catheter-tip syringe having a plunger 303 a and a barrel 304 a, andsecond 302 b catheter-tip syringe having a plunger 303 b and a barrel304 b. The first syringe 302 a and second syringe 302 b are connected tofirst 310 a and second 310 b lengths of tubing which are in turnconnected to a first 101 and second 102 volume displacement deviceconnectors respectively. Preferably, the dual syringes are connectedtogether such that first 303 a and second 303 b plungers operate intandem, and first 304 a and second 304 b barrels can accumulate a volumeof gas from different locations, i.e. atmosphere, or patient. When allcomponents are connected together, a system having a system volume and asystem pressure is created.

[0019] Like the system described in FIGS. 2A and 2B, use of thisembodiment requires three steps. First, a clinician inserts anendotracheal tube into the mouth or nose and throat of a patient. FIG.3A depicts the second step of the process. Prior to connecting the first310 a and second 310 b lengths of tubing to the first 101 and second 102volume detection device connectors, the syringe plungers pushed towardthe tips of the dual syringe. A negative pressure is then created in thesystem by simultaneously withdrawing the plungers from the syringebarrels. A partial vacuum (negative pressure) is created which forcesthe first 110 and second 112 negative pressure response valves to open.Atmospheric air is drawn through the CO₂ detector, through the firstvalve 110 and into the first barrel 304 a in a manner identical to thatdescribed for the inner balloon 202 a (see FIG. 2A). Simultaneously, airis drawn through the ETT 220, through the open second valve 112 and intothe second barrel 304 b. If the ETT is accidentally placed in theesophagus, the walls will collapse around the end of the ETT, makingwithdrawal of the first 303 a and second 303 b plungers difficult. Thus,recoil of the plungers following withdrawal is evidence of improperintubation, whereas free movement of the plungers is evidence of properintubation. FIG. 3B depicts step three of the process which comprisescreating a positive pressure in the system to force gas collected fromstep two out of the first 304 a and second 304 b barrels of the dualsyringe 301 and into a CO₂ detection device 210. First 303 a and second303 b plungers are pushed toward the tips of the dual syringe therebydecreasing the system volume and increasing the system pressure to forcethe gas through out of the barrels. Gas is forced out of the first 304 abarrel, passes through the first 310 a length of tubing, and into thedevice 100 which forces open the first positive pressure response valve111 to allow the gas to escape to the environment. Simultaneously gas isforced out of the second barrel 304 b, through the second 310 b lengthof tubing and into the device 100 which forces a second 113 positivepressure response valve to open, allowing gas to move into the detector210. Gas enters the detector 210 via the intake port 211, passes overthe indicator and then out of the device 210 via the exhaust port 213.If the tube is properly situated in the trachea, the gas will contain aconcentration of CO₂ sufficient to trigger the indicator.

[0020] Each detector provides a different mode. i.e. calorimetric,visual, etc., of assessing the placement of an ETT. The device allowsfor the assemblage of a wide variety of detection devices to cover allenvironments in which it may be employed. The device, may be usedanywhere to assess ETT placement, but is primarily designed for useoutside a fully equipped hospital operating room, such as, for example,in an ambulance or other pre-hospital setting. Through combining twoefficient ETT placement detection devices, in one system, this inventionincreases the accuracy of endotracheal tube placement to almost 100%.Use of this device to create an assemblage of detection devicessignificantly decreases the risk of improper tube placement not uncommonin emergency-type settings, or where a patient has low or no cardiacoutput. The, device is inexpensive, reliable, simple to use, capable ofbeing incorporated with an ETT quickly and effectively by any userregardless of the level of training, does not require a power supply,and is not subject to calibration errors. Because the present deviceallows assemblage of a system that can assess ETT placement withpractical certainty under any set of conditions, the present device isneeded in the field to provide the best, safest level of healthcarepossible.

[0021] One knowledgeable in the art will immediately recognize that thepresent invention is not limited to using a dual syringe, or bulb-in abulb volume displacement device. Any device capable of creating anegative pressure which is adaptable for use with the present devicefalls within the scope of this disclosure. Similarly, the invention isnot limited to use of an EasyCap or capnometer CO₂ detection, nor is itlimited to CO2 detection devices in general. Any gas detection devicethat can be adapted for use with the present device that aids inassessing the location of an ETT falls within the scope of thisdisclosure. Also, other devices utilizing audible, visual, tactile andelectrical signals to indicate the position of an ETT may also beemployed.

What is claimed is:
 1. A connection device for use in assessingplacement of an intubation tube in a patient comprising a tubularhousing comprising at least one conduit and at least one positive and atleast one negative pressure response valve incorporated in said housing,wherein said housing comprises portals adapted for connection to avolume displacement detector, a first portal adapted for connection to agas composition detector; and a second portal adapted for connection toan intubation tube.
 2. The connection device of claim 1, wherein saidpositive and said negative pressure response valves open or close inresponse to positive or negative pressure applied thereon to permitbi-directional flow of gas into and out of said housing.
 3. Theconnection device of claim 2, wherein said device is adapted for quickassembly with a volume displacement detector device, a gas compositiondetector device and an intubation tube.
 4. The connection device ofclaim 3, wherein said assemblage of said connector device, said volumedisplacement device, said gas detection device and said intubation tubecreate a system for assessing proper intubation tube placement in apatient.
 5. The connection device of claim 4, wherein followingintubation of a patient, gas can be withdrawn from said patient intosaid connection device to selectively communicate with said volumedisplacement detector device or said gas composition detector device. 6.The connection device of claim 5, wherein said system provides rapid,alternative measurements to assess intubation tube placement in apatient.
 7. The connection device of claim 6, wherein said measurementsare quantitative, qualitative or both.
 8. The connection device of claim7, wherein said device is constructed of inexpensive materials such thatsaid device may be discarded after use.
 9. The connection device ofclaim 8, wherein said intubation tube is an endotracheal intubationtube.
 10. The connection device of claim 1, wherein said volumedisplacement detector comprises a bulb having at least one collapsible,self-inflating cavity, said bulb configured for connection to saidconnection device.
 11. The connection device of claim 10, wherein saidbulb is visibly responsive to pressure differentials within differentpassages of a patient coincident with the expiratory and inspiratoryphases of a respiratory cycle.
 12. The connection device of claim 10,wherein said device is connected between said bulb and said intubationtube such that in response to expansion of said bulb, negative pressureis generated in said connection device and in said intubation tube. 13.The connection device of claim 10, wherein the rate of expansion andcontraction of said bulb indicates the location of an intubation tubeplaced in a patient.
 14. The connection device of claim 1, wherein saidvolume displacement device is a syringe.
 15. The connection device ofclaim 14, wherein said syringe comprises first and second barrels withfirst and second orifices and a plunger configured to fit into saidfirst or second barrels, said syringe being detachably connected to saidconnection device at said second orifice with an adapter.
 16. Theconnection device of claim 12, wherein withdrawal of said plunger fromsaid syringe provides an physical indication of whether an intubationtube is properly placed.
 17. The connection device of claim 13, whereinsaid physical indication comprises resistance to movement of saidplunger or free movement of said plunger.
 18. The connection device ofclaim 17, wherein said resistance to movement of said plunger isindicative of esophagael intubation, and free movement of said plungeris indicative of tracheal intubation
 19. The connection device of claim18, wherein said gas composition detector is connected to saidconnection device such that upon application of positive pressure insaid system, said positive pressure response valve opens allowing gasobtained from said patient to communicate with said gas compositiondetector device.
 20. The connection device of claim 10, wherein saidpositive pressure in said system is created through compression of saidbulb.
 21. The connection device of claim 19 wherein said positivepressure is created through movement of said plunger barrel toward saidsecond orifice of said syringe.
 22. The connection device of claim 1,wherein said gas composition detection device utilizes a colorimetricindicator to indicate the presence of a specified gas.
 23. Theconnection device of claim 22, wherein said gas is carbon dioxide. 24.The connection device of claim 23, wherein a change in color of saidindicator when exposed to said gas is indicative of tracheal intubation.25. The connection device of claim 24, wherein said gas compositiondetection device does not require calibration.
 26. The connection deviceof claim 25, wherein said gas composition detection device is operablewithout a power source.
 27. The connection device of claim 26, whereinsaid gas composition detection device is a capnometer.
 28. An intubationdetection system for use in determining whether the tip of a tube is ina patient's esophagus or in a patient's trachea, the system comprising;a). a connection device, comprising at least one conduit and a firstportal adapted for connecting to a volume displacement detector, asecond portal adapted for connecting to a gas composition detection anda third portal adapted for connecting an intubation tube; wherein saidfirst, said second and said third portals of said connector deviceincorporate at least one positive or negative pressure response valvedisposed within said at least one conduit; b). a volume displacementdetector device connected to connection device said first portal; c). agas composition detector device connected to said connection device atsecond portal, and; d). an intubation tube connected to said connectiondevice at said third portal.
 29. The system of claim 28, wherein saiddevice is constructed of inexpensive materials such that said device maybe discarded after use.
 30. The system of claim 29, wherein saidintubation tube is an endotracheal intubation tube.
 31. The system ofclaim 28, wherein said volume displacement detection device comprises abulb having at least one collapsible, self-inflating cavity, said bulbhaving an adapter for connection to said connection device.
 32. Thesystem of claim 31, wherein said device is connected between said bulband said intubation tube, such that when said bulb is compressed andthen attached to said connector, negative pressure is generated in saidconnection device and in said intubation tube, said negative pressuresufficient to draw a volume of gas from a patient when said intubationtube is properly positioned in said patient's trachea
 34. The system ofclaim 33, wherein the rate of expansion and contraction of said bulbindicates the location of an intubation tube placed in a patient. 35.The system of claim 28, wherein said volume displacement device is asyringe.
 36. The system of claim 35, wherein said syringe comprisesfirst and second barrels with first and second orifices, and a plungerconfigured to fit into said first and second barrels, said syringe beingdetachably connected to said connection device at said second orificewith an adapter.
 37. The system of claim 36, wherein withdrawal of saidplunger from said syringe provides an physical indication of whether anintubation tube is properly placed.
 38. The system of claim 37, whereinsaid physical indication comprises resistance to movement of saidplunger or free movement of said plunger.
 39. The system of claim 38,wherein said resistance to movement of said plunger is indicative ofesophagael intubation, and free movement of said plunger is indicativeof tracheal intubation
 40. The system of claim 39, wherein said gascomposition detector device is connected to said connection device suchthat upon application of positive pressure in said system, a positivepressure response valve opens allowing gas obtained from said patient tocommunicate with said gas composition detector device.
 41. The system ofclaim 40, wherein said positive pressure in said system is createdthrough compression of said bulb attached to said connection device. 42.The system claim 40, wherein said positive pressure in said system iscreated through movement of said plunger barrel toward said secondorifice of said syringe connected to said connector device.
 43. Thesystem of claim 42, wherein said gas composition detection deviceutilizes a colorimetric indicator to indicate the presence of aspecified gas.
 44. The system of claim 43, wherein said gas is carbondioxide.
 45. The system of claim 44, wherein a change in color of saidindicator when exposed to said gas is indicative of tracheal intubation.46. The system of claim 45, wherein said gas composition detectiondevice does not require calibration.
 47. The system of claim 46, whereinsaid gas composition detection device is operable without a powersource.
 48. The system of claim 26, wherein said gas compositiondetection device is a capnometer.
 49. A method of assessing the properplacement of an endotracheal tube in a patient comprising; a) providingan endotracheal tube; b) inserting said endotracheal tube by its distalend into the air passage of a patient; c) connecting the proximal end ofsaid endotracheal tube to a connection device comprising at least oneconduit and a first portal adapted for connection to a volumedisplacement detector, a second portal adapted for connection to a gascomposition detection; and a third portal adapted for connection to anintubation tube; wherein said first, said second, and said third portalsof said connector device incorporate at least one positive or negativepressure response valve disposed within said at least one conduit. d)connecting a volume displacement detector, a gas composition detectorand an endotracheal tube to said connection device; e) creating anegative pressure in said system through primary activation of saidvolume displacement device to visualize expansion of said volumedisplacement detector; f) creating a positive pressure in said systemthrough secondary activation of said volume displacement device suchthat gas present in said volume displacement device is forced throughsaid connection device and into said gas composition detection devicefor analysis; and g) assessing data obtained from said volumedisplacement detection device and said gas composition device todetermine if a patient has been properly intubated.
 50. A kit comprisingcomponents that may be assembled to provide a device for assessing theproper placement of an endotracheal tube in a patient, the componentsincluding; a). A connection device comprising a tubular housingcomprising at least one conduit and at least one positive and at leastone negative pressure response valve incorporated in said housing,wherein said housing comprises portals adapted for connection to avolume displacement detector, a first portal adapted for connection to agas composition detector; and a second portal adapted for connection toan intubation tube. b). a volume displacement detector; c). a gascomposition detector; and d). an intubation tube.
 51. The kit of claim50, wherein said components are designed such that all components may berapidly assembled to create a system for assessing intubation tubeplacement in a patient.
 52. The kit of claim 50, wherein said volumedisplacement detector device is a bulb having at least one collapsible,self-inflating cavity, said bulb having an adapter for connection tosaid connection device.
 53. The kit of claim 50, wherein said volumedisplacement device is a syringe, said syringe comprising first andsecond barrels with first and second orifices, and a plunger configuredto fit into said first and second barrels, said syringe being detachablyconnected to said connection device at said second orifice with anadapter.
 54. The kit of claim 50, wherein said gas composition detectiondevice utilizes a colorimetric indicator that changes color when exposedto a specified concentration of gas.
 55. The kit of claim 50, whereinsaid system is operable without calibration.
 56. The kit of claim 50,wherein said system is operable without a power source.
 57. The kit ofclaim 50, wherein said components are sized for use with an adultpatient.
 58. The kit of claim 50, wherein said components are sized foruse with an juvenile patient.